Company: Ortho-Clinical Diagnostics
Date of Enforcement Report 8/24/2016
Class lI:
PRODUCT
ORTHO ProVue Analyzers; Product Code MTS213784; Unique Device Identifier (GTIN) 10758750006014
Recall Number B-0686-16
REASON
ORTHO ProVue Analyzers, with suboptimal reference images and/or Brillo values outside of specification, were distributed.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 6/14/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
23 analyzers
DISTRIBUTION
Nationwide and Canada
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